Table 1 Schedule of events

Visit number

1

2

3

4

5

6

7

--

Day of visit

Up to day −7

1

2

5±2

8+1

11+7

30±7

Variable

Informed consent

X

Review eligibility criteria

X

X

Serum HCG pregnancy test

X

Urine pregnancy test

X

Demographics

X

Height and weight

X

Medical history

X

Medication history

X

Review of systems

X

X

X

X

X

X

X

X

Treatment assignment

X

Administration of study product

X

Concomitant medications

X

X

X

X

X

X

X

Physical examination

X

Symptom-directed physical examination

X

X

X

X

X

X

X

Vital signs

X

X

X

X

X

X

X

X

Spirometry

X

X

X

X

X

X

X

X

Sputum collection for microbiology and phage pharmocokinetics

X

X

X

X

X

X

X

X

Clinical chemistry

X

X

X

X

X

X

X

Liver function tests

X

X

X

X

X

X

X

X

Hematology

X

X

X

X

X

X

X

Serum for phage pharmacokinetics

X

X

Cystic Fibrosis Questionnaire-Revised (stage 2 only)

X

X

Cystic Fibrosis Respiratory Symptom Diary (stage 2 only)

X

X

X

X

X

X

X

Safety assessment

X

X

X

X

X

X

X

Events of special interest

X

X

X

X

X